Evaluation of One-stop Strategy of EVAR and PCI

Coronary Artery Disease Clinical Trial

Official title:

Evaluation of the Strategy of "One-stop" Endovascular Treatment for Concomitant Coronary Artery Disease and Aortic Atherosclerotic Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03540342
• Other study ID #: Z171100000417021
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2018
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Min Yang, MD
• Phone: +861088396173
• Email: 13810727489[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is designed to evaluate the safety and effectiveness of the "one-stop" endovascular intervention strategy for patients with concomitant coronary artery disease and aortic atherosclerotic disease. It is a registration study, which will consecutively enroll at least 50 patients with at least 30 subjects receiving one-stop strategy.

Description:

It is a registration study, at least 50 patients will be consecutively enrolled and then be allocated into one-stop strategy group or staging strategy group with at least 30 subjects receiving one-stop strategy. In one stop strategy group, percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR). In staging strategy group, PCI will be performed several days after EVAR. The safety and effectiveness will be assessed between the two groups untill 1 year after the operation. The economic index will be evaluated.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Aged from 18 years to 75years, male or female;

• Aortic atherosclerotic disease with the indication of EVAR;

• Coronary heart disease with the indication of PCI;

• Provided informed consent.

Exclusion Criteria:

• Acute aortic dissection

• Acute coronary syndrome

• Dysfunction of coagulation system

• Patients with gastrointestinal hemorrhage

• Known allergy to contrasts or antiplatelet drugs

• Renal dysfunction (GFR=60ml/min)

• Patient with multi-branch coronary preferred CABG

Related Conditions & MeSH terms

• Aortic Atherosclerotic Disease
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• One stop strategy group
Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences, Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-Emergent Adverse Events	The incidence of a composite endpoint of all-cause mortality, myocardial infarction, rupture of aorta, hematoma, bleeding events (BARC=2 grade), pseudoaneurysm, stent thrombosis	12 months
Secondary	Operative success rate		12 months
Secondary	Average in-patient time		12 months
Secondary	Average cost during hospitalization		12 months